PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
PROMUS PREMIER
Technical Success Rate
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Target Lesion Revascularization (TLR) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Lesion Failure (TLF) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Target Vessel Revascularization (TVR) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months
Target Vessel Failure (TVF) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
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Non-cardiac Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Cardiac Death or MI Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death or MI Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
All Death/MI/TVR Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Clinical Procedural Success Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Percent Diameter Stenosis (%DS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
In-stent and In-segment Minimum Lumen Diameter (MLD)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Acute Gain
as measured by angiographic core lab, change from baseline for target lesions
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
Longitudinal Stent Deformation (LSD) Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months